Pruritus and Pemphigoid in Nursing Home Patients

NCT ID: NCT02823067

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-01-01

Brief Summary

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The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.

Detailed Description

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Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 30% of nursing home patients. Clinical and experimental evidence suggests pruritus in elderly patients may be linked to pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases and mainly affects the elderly. It is successfully treatable with systemic therapy. However, pemphigoid is often missed as a cause of pruritus in elderly patients (nonbullous cutaneous pemphigoid). Although nursing home patients and patients with dementia in particular have the highest risk for development of pemphigoid, no study has been performed in this population so far. Including serological screening for pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may be an unrecognized cause of neuropsychiatric symptoms in nursing home patients with dementia.

Conditions

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Pemphigoid Pruritus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Nursing home patients

Nursing home patients aged 65 years or above. One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

Blood sample

Intervention Type OTHER

One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

Interventions

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Blood sample

One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inpatient of a nursing home
* Age 65 years or above
* Subject or their official representatives have signed informed consent

Exclusion Criteria

* Age below 65 years
* Subjects who do not have signed informed consent
* Receiving treatment with any systemic immunosuppressive agents
* Terminally ill patients with a life expectancy of less than 4 weeks
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.F. Jonkman

OTHER

Sponsor Role lead

Responsible Party

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M.F. Jonkman

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcel Jonkman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METc 2015/605

Identifier Type: OTHER

Identifier Source: secondary_id

NTR5843

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL56232.042.15

Identifier Type: -

Identifier Source: org_study_id

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